Estimands in the presence of high and unbalanced drop out rates – a case study in the German HTA system – Interview with Lovisa Berggren

Every statistician in the health sector must know about estimands and how to apply the estimand framework.

In this episode we introduce the topic using a case study. We’ll cover

• How does the HTA system in Germany work?
• What are the 4 critical elements for the estimands framework?
• How does the application of the estimand framework differ in study planning vs post-hoc?

Lovisa runs also a workshop during a corresponding upcoming one-day PSI workshop on RWE.

You can register for the one-day event at http://www.psiweb.org/events/psi-events.

About Lovisa Berggren

Lovisa Berggren (MSc), Senior statistical consultant, Freelancing consultant specialized in HTA submissions, data mining and analyses of integrated clinical trials data. With a focus on Phase III and IV neuroscience, autoimmune and oncology.

Lovisa gained her initial experienced as a statistician working 3.5 years with AstraZeneca. During this time she prepared and attended two public oral advisory committee meetings with the FDA and one EMA oral hearing for new indications with Quetiapine (neuroscience). Her job also including leading and coordinating big teams of statisticians and programmers under high pressure. A

fter AstraZeneca Lovisa joined ImClone for 1.5 years as a contractor working on two phase III trials in oncology. During the restructuring and merger of ImClone and Eli Lilly Lovisa moved over to work as a contractor for Eli Lilly. During her 5.5 years with Lilly she has worked with a number of datamining projects and publications (autoimmune and neuroscience). As well as in the role of lead statistician for the HTA submission of ixekizumab. Lovisa is currently working part time for Eli Lilly and Cogitars.

In parallel, she conducting her PhD at the UMIT University in Austria. Her PhD thesis focuses on methods for evaluating consistency of treatment effects in HTA reimbursement submissions.

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